GB-0895 for Severe Uncontrolled Asthma (SOLAIRIA-2)

This study, called SOLAIRIA-2, is looking at whether GB-0895 can help adults and adolescents (ages 12 to 80) with severe asthma that isn't well-controlled by their current medications. You must have had asthma for at least two years and be on specific asthma controllers for a certain time. Participants will receive either GB-0895 or a placebo (an inactive substance) every six months for 52 weeks. The main goal is to see if GB-0895 can reduce the number of asthma attacks (exacerbations) over this period. The study aims to enroll about 786 people globally, but its current status is unclear.

Study design
This is a global, randomized, double-blind, placebo-controlled Phase 3 study involving approximately 786 participants.
What's involved
You would have visits every 1-2 months after the first month, for a total treatment period of 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 90 weeks, or potentially up to 142 weeks if you join an optional open-label extension.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07359846

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

Recruiting
PHASE3Ages 12–80InterventionalTreatment
Generate Biomedicines
~786 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:GB-0895Placebo

At a glance

Recruiting sites
68 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.
Measured over From Day 1 (randomization) to Week 52
Severe Asthma
68 sites across 44 states
Florida6
Tokyo5
England5
California4
Belgrade3
Texas2
Buenos Aires2
Niigata2
  • Snodgres · STUDY_DIRECTOR · Generate Biomedicines

Opens a ready-to-send draft in your own email app — review before sending.

  • To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.From Day 1 (randomization) to Week 52

    The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.